Article history: The purpose of this work was to explore NIR spectroscopy as a PAT tool to monitor the formation of Received 7 September 2011 ibuprofen and nicotinamide cocrystals during extrusion based solvent free continuous cocrystallization Received in revised form (SFCC). Drug and co-former were gravimetrically fed into a heated co-rotating twin screw extruder to 20 December 2011 form cocrystals. Real-time process monitoring was performed using a high temperature NIR probe in the Accepted 21 December 2011 extruder die to assess cocrystal content and subsequently compared to off-line powder X-ray diffraction Available online 17 January 2012 measurements. The effect of processing variables, such as temperature and mixing intensity, on the extent of cocrystal formation was investigated. NIR spectroscopy was sensitive to cocrystal formation with the Keywords: −1 appearance of new peaks and peak shifts, particularly in the 4800–5200 cm wave-number region. PXRD Cocrystals conﬁrmed an increased conversion of the mixture into cocrystal with increase in barrel temperature and NIR spectroscopy screw mixing intensity. A decrease in screw rotation speed also provided improved cocrystal yield due PAT QbD to the material experiencing longer residence times within the process. A partial least squares analysis in Process analytics this region of NIR
International Journal of Pharmaceutics – Elsevier
Published: Apr 15, 2012
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